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Clinical Hepatology
IDDF2024-ABS-0201 Long-term safety profile of tenofovir alafenamide in chronic hepatitis B patients; final 8-year results of 2 phase 3 studies
  1. Young-Suk Lim1,
  2. Henry Lik Yuen Chan2,
  3. Kosh Agarwal3,
  4. Patrick Marcellin4,
  5. Maurizia Brunetto5,
  6. Wan-Long Chuang6,
  7. Harry Janssen7,
  8. Scott Fung8,
  9. Namiki Izumi9,
  10. Maciej Jablkowski10,
  11. Frida Abramov11,
  12. Hongyuan Wang11,
  13. Leland Yee11,
  14. John Flaherty11,
  15. Calvin Pan12,
  16. Dr Shalimar13,
  17. Wai-Kay Seto14,
  18. Edward Gane15
  1. 1Asan Medical Center, University of Ulsan College of Medicine, Korea, South
  2. 2Faculty of Medicine, the Chinese University of Hong Kong, HMA Office, Hong Kong
  3. 3Institute of Liver Studies, King’s College Hospital NHS Foundation Trust, UK
  4. 4Hepatology Department, Hôpital Beaujon, APHP, INSERM, University of Paris, France
  5. 5Azienda Ospedaliero-Universitaria Pisana, Italy
  6. 6Kaohsiung Medical University Hospital, Kaohsiung Medical University, Taiwan
  7. 7Toronto Centre for Liver Disease, University Health Network, Canada
  8. 8University of Toronto, Department of Medicine, Canada
  9. 9Department of Gastroenterology and Hepatology, Japanese Red Cross Musashino Hospital, Japan
  10. 10Medical University of Łódź, Poland
  11. 11Gilead Sciences, USA
  12. 12NYU Langone Health, New York University Grossman School of Medicine, USA
  13. 13All India Institute of Medical Sciences, India
  14. 14Department of Medicine and School of Clinical Medicine, The University of Hong Kong, Hong Kong
  15. 15Auckland Clinical Studies, New Zealand

Abstract

Background In 2 similarly designed double-blind (DB), randomized (2:1), Phase 3 studies (Study 108 in HBeAg-negative [N=425] and Study 110 in HBeAg-positive [N=873] patients), tenofovir alafenamide (TAF) demonstrated non-inferior efficacy with superior renal and bone safety compared to tenofovir disoproxil fumarate (TDF) at week 96. After completing DB treatment, all patients were eligible to receive open-label (OL) TAF through week 384 (year 8). Here, we present the final safety results at year 8.

Methods In a pooled analysis, treatment-emergent adverse events (AEs), serious AEs (SAEs), discontinuations, and laboratory abnormalities were assessed in patients who received OL TAF. Changes from baseline in estimated GFR (by Cockcroft-Gault; eGFRCG) and changes in hip and spine bone mineral density (BMD) by dual x-ray absorptiometry (DXA) scans were assessed.

Results Of 1298 randomized and treated patients, 1157 (89%; 775 TAF; 382 TDF) entered the OL phase. Overall, 974 (75%) participants completed OL study treatment. The overall incidence of patients experiencing AEs was similar among groups (IDDF2024-ABS-0201 Table 1). Rates of Grade 3/4 AEs and AEs leading to discontinuation (D/C) were low and similar among groups. Few Grade 3/4 AEs or SAEs were related to the study drug. Overall, the most common Grade 3/4 lab abnormalities (>2%) were increased amylase (TAF 1.9%, TDF-TAF 2.7%), creatine kinase (TAF 1.4%, TDF-TAF 2.1%), fasting cholesterol (TAF 1.4%, TDF-TAF 2.9%), fasting LDL (TAF 5.9%, TDF-TAF 8.0%), and urine glucose (TAF 5.2%, TDF-TAF 2.7%). After experiencing declines in eGFRCG and hip/spine BMD with TDF treatment in the DB phase, renal and bone outcomes improved following the switch to OL TAF with minimal change through year 8. Overall, low rates of hepatocellular carcinoma (HCC) were observed over 8 years, with 11 cases occurring in the DB and 10 in the OL phases of the study.

View this table:
Abstract IDDF2024-ABS-0201 Table 1

OL safety parameters

Conclusions Long-term TAF treatment was safe and well tolerated, with minimal changes in eGFRCG and BMD occurring over 8 years.

https://doi.org/10.1136/gutjnl-2024-IDDF.188

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